Safety Alert for BBL MGIT Mycobacteria Indicator Tube (reg 10033430437), BBL MGIT 960 PZA Medium (reg 10033430381), BBL MGIT Mycobacteria Growth Indicator Tube (reg 10033430437).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Becton Dickinson and Company.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    902
  • Date
    2008-03-07
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    The manufacturer of the products in the United States of America, Becton Dickinson and Company, received a limited number of complaints (5 complaints between 2003 and 2008) reporting the presence of cracks in culture media tubes for mycobacteria detection. In only one case was found leaking of the medium after inoculation. Becton Dickinson cautions against the fact that pathogenic microorganisms, including hepatitis B virus and acquired immunodeficiency virus (HIV), may be present in clinical samples, which makes the presence of cracking in the tubes of these products a risk factor for the user. According to the company, before using culture medium vials, the user should carefully examine the vials for evidence of contamination or damage - if any problem is verified, the tube should be discarded immediately. The Technovigilance Unit is following up on this case.
  • Reason
    Possibility of presence of cracks in culture medium tubes for the detection of microorganism mycobacterium tuberculosis.
  • Action
    The company Beckton Dickinson Industries Surgical Ltda. Requests that the use of the above mentioned products be interrupted and that the remaining quantities be returned to the company, to perform visual inspection in 100% of the products marketed. According to the company, the existing stock in the market will be replaced by boxes with 100% of the pipes inspected.

Manufacturer

  • Source
    ANVSANVISA